Safety Monitoring Plan

The safety monitoring plan details the system from appropriate oversight and monitoring of the conduct of the clinical trial to ensure the safety and welfare of participants. The scope of the safety plan is dependent on the size and risk of the clinical trial and can be included as a part of the Data and Safety Monitoring Plan.

The safety plan should include the following elements as required:

  • Entities responsible for ensuring safety- Principal investigator, study coordinator, safety monitor, sponsor, IRB.
  • Established parameters for subject safety- vital signs, blood tests, behavioral health monitoring and scoring.
  • Subject stopping rules based on exclusion criteria and adverse responses.
  • Study stopping rules in response to unanticipated problems and risks to subjects.
  • Reporting mechanisms and plans for reporting deviations and adverse events to the designated IRB, FDA, sponsor, or data/safety monitoring board.

Source: U.S. Food and Drug Administration & U.S. Department of Health and Human Services. (2013, August). Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring. FDA.